EP0957775A4 - Devices and methods for performing a vascular anastomosis - Google Patents
Devices and methods for performing a vascular anastomosisInfo
- Publication number
- EP0957775A4 EP0957775A4 EP96906389A EP96906389A EP0957775A4 EP 0957775 A4 EP0957775 A4 EP 0957775A4 EP 96906389 A EP96906389 A EP 96906389A EP 96906389 A EP96906389 A EP 96906389A EP 0957775 A4 EP0957775 A4 EP 0957775A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- vessel
- wall
- graft
- anastomosis
- flange
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Classifications
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- A61B17/1204—Type of occlusion temporary occlusion
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Definitions
- the 3M-Unilink device for end-to-end anastomosis (U.S. patent numbers 4,624,257; 4,917,090; 4,917,091) is designed for use in microsurgery, such as for reattaching vessels severed in accidents.
- This device provides an anastomosis clamp that has two eversion rings which are locked together by a series of impaling spikes on their opposing faces.
- this device is awkward for use in end-to-side anastomosis and tends to deform the target vessel; therefore it is not currently used in CABG surgery. Due to the delicate process needed to insert the vessels into the device, it would also be unsuitable for port-access surgery.
- attachment spikes on the surfaces of either the inner or the outer flange provide additional grip on the graft vessel and/or the target vessel.
- the attachment spikes are isolated from the blood flow lumens of the graft vessel and the target vessel so that they do not compromise the anastomotic seal or the structural integrity of the anastomotic attachment.
- Catheter devices are described which can be used as part of the total anastomosis system for isolating a portion of the target artery to facilitate performing the anastomosis procedure.
- One catheter device is configured to isolate a portion of the ascending aorta wall without occluding blood flow through the lumen of the aorta.
- a second catheter device is configured to be delivered by a transluminal approach for isolating a portion of a coronary artery during the anastomosis procedure.
- a third catheter device is configured to be delivered through the lumen of the graft vessel for isolating a portion of a coronary artery during the anastomosis procedure,
- Figs. 5A-5G are side cross section view showing the sequence of operations for creating an end-to-side anastomosis with the two-piece anastomosis staple device of Fig. 1.
- Fig. 10 is a cross sectional view of the one-piece anastomosis staple device of Fig. 9 being actuated to form an end-to-side anastomosis.
- Figs. 18A-18F show a second alternate construction of the two-piece anastomosis staple device of Fig. 1.
- Figs. 31A-31F show a first embodiment of an anastomotic device combining a fastening flange with a plurality of staple members.
- Figs. 46A-46D illustrate a second embodiment of the anastomosis system using an anastomosis device with an inner fastening flange, an outer flange and staple members made of a superelastic alloy.
- the distal end of the anchor member 106 and the attachment legs 105 may be angled with respect to the ring-shaped frame 104 to permit an angled takeoff of the graft vessel from the target vessel.
- Each gripping finger 144 has a axial slot 145 alongside of it which is at least as wide as the attachment legs 105.
- the axial slot 145 connects with a transverse slot 146 in the side of each gripping finger 144.
- the anchor member 101 of the anastomosis staple 100 is loaded onto the staple retainer 123 by aligning the attachment legs 105 with the ends of the axial slots 145, pushing the attachment legs 105 to the bottom of the axial slots 145, the turning the anchor member 101 ' counterclockwise until the attachment legs 105 enter the transverse slots 146 in the side of the gripping fingers 144.
- a one-piece version of the anastomo ⁇ is staple device of the present invention along with a specially adapted staple applying tool will now be described in detail.
- a tubular member analogous to the coupling member of the previously described embodiment, is permanently attached to a circular staple member, which is analogous to the anchor member 101 of the previously described embodiment.
- the outer tube 180 is slidable with re ⁇ pect to the inner tube 181 by actuating the lever 185 of the staple applying tool 179 which engages a pair of pins 186 attached to the exterior of the outer tube. Pulling the lever 185 advances the outer tube 180 distally over the inner ube 181. A return spring 187 attached to the lever 185 returns the lever 185 and the outer tube 180 to their unactuated positions.
- the staple 167 is actuated by pulling on the lever 185, which moves the outer tube 180 distally until the staple driver 193 at the distal end of the outer tube 180 bears on the attachment legs 168.
- the attachment legs 168 bend at the fulcrum 176 where they attach to the tubular member 164.
- the arc-shaped third segments 175 of the attachment legs 168 penetrate and traverse the wall of the target vessel 150. Once the third segments 175 of the attachment legs 168 have traversed the wall, the staple 163 begins to compress the ti ⁇ ue of the target vessel wall 150 radially against the distal tubular extension 166 of the anastomosis staple 163 by any of the mechanism ⁇ previou ⁇ ly discussed.
- Fig. 16 shows another potential configuration for the staple legs 194 of the one-piece anastomosis staple 195.
- the staple legs 194 have a compound curved transition segment 197 which provides two different axes of rotation for the staple legs 194 as they are actuated.
- the staple legs 194 attach to the proximal end of the tubular body member 198.
- a fir ⁇ t segment 199 of the staple leg 194 extends approximately radially from the point of attachment 206.
- a third segment 202 attaches the second segment 201 to the fourth, and most distal, segment 203 of the staple leg.
- the graft vessel 148 is prepared by placing it through the lumen of the tubular coupling member and everting the end 192 of the graft vessel 148 over the outside of the coupling member 245.
- the coupling member 245 with the end 192 of the graft vessel 148 attached is collapsed or folded and inserted into the proximal tubular extension 244 of the anchor member 238.
- the anastomo ⁇ is fitting 355 is part of a complete anastomosi ⁇ system for forming and applying the anastomosis fitting 355 to create an end-to-side anastomosi ⁇ .
- a ⁇ et of three forming dies 369, 370, 371 are configured to deform the attachment legs 357 of the anastomo ⁇ i ⁇ fitting 355 from their initial position 357 to a deployed position 357' , and a specialized grasping tool 372 is used to insert the deployed inner tubular member 356 through an opening 267 in the side wall of the target vessel 355.
- the bent attachment leg ⁇ 357' and the distal end 360 of the tubular member, with the everted end 259 of the graft vessel 254 attached are inserted through an opening 267 in the target vessel wall 255 that has previously been made with an aortic punch or similar instrument, as shown in Fig. 301.
- the opening 367 is preferably made so that it is approximately the ⁇ ize of the external diameter of the tubular member 356 to provide compre ⁇ sion around the everted end 259 of the graft vessel 254 to help create an anastomotic seal.
- the inner tubular member 356 is pulled back with enough force to cause the sharpened distal ends 361' of the attachment legs 357' to pierce the interior surface 257 of the target vessel wall 255.
- This action also serves to approximate the everted end 259 of the graft vessel 254 with the interior surface 257 of the target vessel 255 to effect the desired intimal surface-to-intimal surface approximation between the two vessels.
- the sharpened distal end ⁇ 361' of the attachment leg ⁇ 357' can be a ⁇ isted in piercing the target vessel wall 255 by pressing on the exterior 258 of the target vessel wall 255 with an elastomeric-tipped probe while maintaining some tension on the tubular body 356 of the fitting using the grasping tool 372.
- the anastomosis is completed by sliding the central orifice 364 of the outer flange 358 over the exterior surface of the tubular member 356 and moving the outer flange 358 distally while keeping some tension on the tubular member 356 to create tissue compression at the anastomosis site to assure an ana ⁇ tomotic seal.
- the anvil 405 is pa ⁇ ed through the graft vessel lumen 249 in an orientation axially aligned with of the shaft 408 and, once it is in the lumen 256 of the target vessel 255, it is articulated at 90 * , a ⁇ ⁇ hown in Fig. 31A.
- a cylindrical or olive- ⁇ haped centering element 409 such as an inflatable centering balloon on the shaft 408, can be used to center the shaft 408 of the anvil 405 within the lumen 249 of the graft vessel 254 and within the central orifice 393 of the flange 291.
- the anvil 305 can now be rotated about the shaft 308 to deform the distal ends 398 of the attachment legs 399.
- the application device 403 can operate by two different mechanisms.
- the shape-memory property of the alloy can be used to facilitate loading the staples 411 into the flange 412.
- the staple 411 would first be annealed in the desired shape for the final staple. Then, the staple 411 would be plastically deformed below its transition temperature to straighten out the distal bend 427. The straightened staples 411 are easily inserted into the holes 414 in the flange 412. Finally, the staples 411 are heated above their shape-memory transition temperature to make them resume their annealed shape.
- This variation differs from the previou ⁇ one in that the di ⁇ tal ⁇ egment 444 i ⁇ bent at an acute angle to the central ⁇ egment rather than being a fully formed hook.
- the S- ⁇ haped staples 432 are annealed in the desired configuration so that they will retain the annealed shape.
- the extremely resilient nature of the superelastic alloy allows the ⁇ taple members 432 to be completely straightened without causing pla ⁇ tic deformation of the staples so that they will return to their annealed shape.
- Figs. 35A-35F show another variation of an anastomosis device 447 using a fastening flange 448 and attachment staple 449 combination.
- the fastening flange 448 is a cylindrical member with an internal lumen 450 large enough to accommodate the external diameter of the graft vessel 254.
- the flange 448 has a distal surface 451 over which the free end 254 of the graft vessel 259 may be everted.
- An annular ridge 452 around the outer surface of the flange 448 at the distal end helps to hold the everted graft ves ⁇ el 259 in place and serves as part of a locking mechani ⁇ m for the attachment staples 449, as will be described below.
- the application tool 486 is used to approximate the end 259 of the graft vessel 254 to an opening 267 that has previously been made in the wall of the target vessel 255.
- a tubular staple driver 489 slides telescopically over the exterior of the tubular inner member 485.
- the fastening flange 482 is moved distally by sliding the staple driver 489 axially with respect to the inner tubular member 485, which forces the sharpened distal ends 490 of the integral staple legs 483 through the everted wall 259 of the graft vessel 254 and the wall of the target vessel 255.
- the staple legs 483 Once the staple legs 483 have traversed the graft vessel 254 and target vessel walls 255, the distal ends 490 of the staple legs 483 are deformed to lock the anastomosis device 481 in place as shown in Fig. 38C.
- the inner ring 497 is pressed into the everted graft vessel wall 259 and simultaneously rotated in a clockwise direction, thereby driving the staple members 497 through the graft vessel wall 259 and the target vessel wall 255.
- the outer ring 498 is moved distally along the graft vessel 254 until it is concentric with the inner ring 497.
- the outer ring 498 is pressed into the everted graft vessel wall 259 and simultaneously rotated in a counterclockwise direction, driving the staple members 500 through the graft vessel wall 259 and the target vessel wall 255.
- the locking features 501 of the outer ring 498 coincide with the locking features 502 of the inner ring 497, the outer 498 and inner 497 rings become locked together.
- the staple legs 514 combine two such J-shaped staple legs 514 with a crossbar 515 that connects the proximal ends of the staple legs 514 to form staple ⁇ 505 that are roughly U-shaped when viewed from the front or from the top, as in Fig. 4IE.
- the staple legs 514 are formed with a central segment 516 that is attached at an acute angle to a proximal segment 517.
- a short intermediate segment 518 may be used to connect the proximal segment 517 to the central segment 516 of the ⁇ taple member 505.
- the proximal end of each of the proximal segments 517 is joined to the crossbar 515 of the staple member 505.
- the side wall 576 of the distal chamber 572 has pair of opposing open-ended slot ⁇ 577 that are sized to fit over the T-shaped handle 560 of the staple driver 559 and allow the handle 560 to move axially within the slots 577.
- the proximal chamber 573 has an internal thread 579 that matches an external thread 579 on the clamp knob 570.
- a counterbored hole 580 through the internal wall 574 connects the proximal 573 and distal 522 chambers.
- the proximal end of the shaft 589 is threaded to attach it to the punch knob 571.
- the punch knob 571 has a distal extension 592 which is threaded to fit into a threaded hole 593 on the proximal end of the clamp knob 570.
- the anastomosis system which includes the anastomosis device 533 attached to the graft vessel 254 and the application instrument 536, is prepared to perform an end-to-side anastomosis between the graft vessel 254 and a target ves ⁇ el 255.
- the operation of the application instrument 536 is illu ⁇ trated in Figs. 45A-45E.
- a slit 596 is made in the wall of the target vessel 255 with a scalpel or other sharp instrument. If it has not been done already, the clamp 569 of the punch mechanism 551 is advanced distally by turning the clamp knob 570 until the clamp surface 588 extends slightly beyond the cutting edge 584 of the cutter 567, and the anvil 568 of the punch mechanism 551 is advanced distally by turning the punch knob 571 until the anvil head 591 extends distally from the application instrument 536.
- the anvil head 591 of the punch mechanism 551 is inserted through the slit 596 into the lumen 256 of the target ves ⁇ el 255, and the di ⁇ tal edge 541 of the fastening flange 534 with the everted end 259 of the graft vessel 254 attached is approximated to the exterior surface 258 of the target vessel 255, as shown in Fig. 45A.
- the target vessel wall 255 is then clamped by the punch mechanism 551 by turning the punch knob 571 to move the anvil head 591 proximally until the target vessel wall 255 is firmly gripped between the anvil head 591 and the clamp surface 588, as ⁇ hown in Fig. 45B.
- the clamp feature of the punch mechani ⁇ m 551 prevents the cutter 567 from prematurely cutting through the wall of the target vessel 255 and it provides a firm support to the target vessel wall 255 for the stapling step which follows.
- the staple members 636 are preferably formed from wire made of a highly resilient biocompatible metal such as a spring-tempere alloy of stainless steel, titanium, or cobalt, or more preferably of a superela ⁇ tic metal alloy, ⁇ uch a ⁇ a nickel-titanium alloy.
- catheter devices described above are not limited in their use to CABG surgery. Either of the catheter devices could easily be modified to be the appropriate size for use during other bypass operations such as aorto-femoral bypass or femoral-femoral bypass.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP02018253A EP1266628B1 (en) | 1995-02-24 | 1996-02-13 | Devices for performing a vascular anastomosis |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/394,333 US5695504A (en) | 1995-02-24 | 1995-02-24 | Devices and methods for performing a vascular anastomosis |
US394333 | 1995-02-24 | ||
PCT/US1996/001890 WO1996025886A1 (en) | 1995-02-24 | 1996-02-13 | Devices and methods for performing a vascular anastomosis |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP02018253A Division EP1266628B1 (en) | 1995-02-24 | 1996-02-13 | Devices for performing a vascular anastomosis |
Publications (3)
Publication Number | Publication Date |
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EP0957775A1 EP0957775A1 (en) | 1999-11-24 |
EP0957775A4 true EP0957775A4 (en) | 2003-05-28 |
EP0957775B1 EP0957775B1 (en) | 2009-04-29 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP96906389A Expired - Lifetime EP0957775B1 (en) | 1995-02-24 | 1996-02-13 | Devices for performing a vascular anastomosis |
Country Status (9)
Country | Link |
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US (2) | US5695504A (en) |
EP (1) | EP0957775B1 (en) |
JP (1) | JPH11500642A (en) |
AT (2) | ATE413138T1 (en) |
AU (1) | AU708815B2 (en) |
CA (1) | CA2213580A1 (en) |
DE (2) | DE69637740D1 (en) |
ES (1) | ES2324563T3 (en) |
WO (1) | WO1996025886A1 (en) |
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CA2213580A1 (en) | 1996-08-29 |
JPH11500642A (en) | 1999-01-19 |
ES2324563T3 (en) | 2009-08-10 |
ATE413138T1 (en) | 2008-11-15 |
DE69637740D1 (en) | 2008-12-18 |
US5817113A (en) | 1998-10-06 |
AU708815B2 (en) | 1999-08-12 |
US5695504A (en) | 1997-12-09 |
EP0957775B1 (en) | 2009-04-29 |
DE69637915D1 (en) | 2009-06-10 |
ATE429859T1 (en) | 2009-05-15 |
WO1996025886A1 (en) | 1996-08-29 |
EP0957775A1 (en) | 1999-11-24 |
AU4978196A (en) | 1996-09-11 |
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